Status:
UNKNOWN
Synvisc Injections for Lumbar Facet Joint Pain
Lead Sponsor:
Sheltering Arms Physical Rehabilitation Hospitals
Collaborating Sponsors:
Genzyme, a Sanofi Company
Virginia Commonwealth University
Conditions:
Joint Pain
Eligibility:
All Genders
30+ years
Phase:
PHASE3
Brief Summary
The objective of this investigation is to evaluate the safety and efficacy of viscosupplementation in treating symptomatic lumbar facet joint arthropathy. The intended use of the device (Synvisc) is t...
Detailed Description
Patients will enter the study once the putatively painful joint or joints have been confirmed by single blind, double local-comparative anesthetic blockade. The joint(s) suspected by historical featur...
Eligibility Criteria
Inclusion
- Ongoing axial lumbar pain, greater than any lower limb pain if present, for \> 3 months duration.
- No improvement despite 6-8 weeks of physical therapy (PT), oral nonsteroidal anti-inflammatory drugs (NSAIDs), relative rest, and activity modification.
- Radiographic evidence of facet joint arthrosis on advanced imaging studies defined as joint capsule hypertrophy, osteophyte formation, joint space narrowing, irregularity of joint contours, subchondral sclerosis, and synovial cyst formation.
- Age 30 years or older.
- Positive double, local comparative anesthetic diagnostic block injections at one unilateral or bilateral joint(s).
Exclusion
- Pregnancy.
- Active or remote history of spinal malignancy.
- Active infection.
- Blood dyscrasias/coagulopathy.
- Unwillingness to follow through with follow up evaluations.
- Negative response to all diagnostic facet joint injections.
- Application for/currently receiving worker's compensation.
- Allergy to avian products.
- Allergy to prior viscosupplementation products.
- Prior viscosupplementation of lumbar facet joints.
- Improper intra-articular needle placement at time of Synvisc injection.
- Painful bilateral or multi-level facet joint arthropathy.
Key Trial Info
Start Date :
May 1 2006
Trial Type :
INTERVENTIONAL
End Date :
May 1 2008
Estimated Enrollment :
15 Patients enrolled
Trial Details
Trial ID
NCT00325845
Start Date
May 1 2006
End Date
May 1 2008
Last Update
September 13 2006
Active Locations (1)
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1
Sheltering Arms Spine and Sport Center; St. Mary's Hospital
Richmond, Virginia, United States, 23226